Risk Evaluation and Mitigation Strategies

Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs.[1] The REMS program was formalized in 2007.

The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program.[2] REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacture of the brand name drug.[1] The FDA may remove the REMS requirement if it is found to not improve patient safety.[3]

The REMS program developed out of previous systems dating back to the 1980s for monitoring the use of a small number of high-risk drugs such as the Accutane, which causes serious birth defects, Clozaril, which can cause agranulocytosis, and Thalidomide, which is used to treat leprosy but causes serious birth defects.[4] The 2007 Food and Drug Administration Amendments Act created section 505-1 of the Food, Drug, and Cosmetic Act which allowed for the creation of the REMS program for applying individual monitoring restrictions to medications.[5]

Some of the provisions required by the REMS program are training and certification of physicians allowed to prescribe the drug, requiring that the drug be administered in a hospital setting, requiring pharmacies to verify the status of patients receiving REMS drugs, requiring lab testing of patients to ensure that health status is satisfactory, or requiring that patients be entered into a registry.[6]

  1. ^ a b Brennan, Z. (31 May 2018). "REMS Draft Guidance: FDA Looks to Deal With Exploited Requirements". Retrieved 22 June 2018.
  2. ^ Research, Center for Drug Evaluation and. "Risk Evaluation and Mitigation Strategies (REMS) - Frequently Asked Questions (FAQs) about REMS". www.fda.gov. Retrieved 22 June 2018.
  3. ^ "FDA Removes Risk Evaluation Management Strategies (REMS) for ESAs". ASCO. 13 April 2017. Archived from the original on 23 June 2018. Retrieved 22 June 2018.
  4. ^ Research, Center for Drug Evaluation and. "Risk Evaluation and Mitigation Strategies (REMS) - FDA's Role in Managing Medication Risks". www.fda.gov. Retrieved 22 June 2018.
  5. ^ Dabrowska, A. (26 March 2018). "FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development" (PDF). Retrieved 22 June 2018.
  6. ^ Research, Center for Drug Evaluation and. "Risk Evaluation and Mitigation Strategies (REMS) - What's in a REMS?". www.fda.gov. Retrieved 22 June 2018.